MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TRULIANT PIN PULLER SYRINGE STYLE

Catalog Number	02-029-90-4100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
When re-setting trays in spd after surgery i always check the instruments to make sure they are clean and functioning as expected.When checking the truliant tibia pin puller i noticed that one of the prongs was broken off.The broken pin puller will be sent back to exacetch.Found in spd when cleaning up/resetting trays after surgery.Additional information received from rep: i am unsure what patient or case this happened from as there was multiple knees that day and spd does not categorize washed pans by when each case was.I will check post op x-rays.The prong was not seen with the instruments on spd.It wasn¿t found.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported based on review of the available information, the breakage area of the component being relatively thin which does not offer great safety margin when the instrument is subject to off-axis loading.Off-axis loading when the user applies a bending moment to the device during pin driving/pulling.No information provided in the following section(s): a2, a3, a4, a5, b6, b7, the following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: EXACTECH
• Common Device Name: TRULIANT PIN PULLER SYRINGE STYLE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10946346
• Report Number: 1038671-2020-00636
• Device Sequence Number: 3230859
• Product Code: LXH
• UDI-Device Identifier: 10885862585882
• UDI-Public: 10885862585882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-029-90-4100
• Device Lot Number: 105612050
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other